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OpenTrials
Completed

NCT Number: NCT00000449

Behavior and Naltrexone Treatment for Alcoholics

The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brown University, Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets criteria for alcohol dependence.

Exclusion criteria

  • Current diagnosis of dependence on other substances except nicotine.
  • A history of psychosis or current psychotic symptoms.
  • Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
  • Current use of disulfiram (Antabuse).
  • Evidence of significant cerebral, renal, thyroid, or cardiac disease.
  • History of opioid abuse in the previous year.
  • History of cirrhosis, hepatocellular disease, or elevated bilirubin.
  • Females who are pregnant, nursing, or not using a reliable method of birth control.

Treatment and study plan

naltrexone (Revia)

Drug

Cognitive behavioral therapy

Behavioral

Cue Exposure Treatment

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Nih

Registry information

Official study title

Coping, Exposure, and Naltrexone Treatment With Alcoholics

Important dates

Study completion
2000
First posted
Nov 3, 1999
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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